Important Safety Information for Humalog®

What is the most important information I should know about Humalog?

Do not change the insulin you use without talking to your healthcare provider. Doses of oral antidiabetic medicines may also need to change if your insulin is changed.

Test your blood sugar levels as your healthcare provider instructs.

When used in a pump, do not mix Humalog with any other insulin or liquid.

Who should not take Humalog?

Do not take Humalog if your blood sugar is too low (hypoglycemia) or if you are allergic to insulin lispro or any of the ingredients in Humalog.

Before using Humalog, what should I tell my healthcare providers?

About all of your medical conditions, including liver, kidney, or heart problems.

If you are pregnant or breastfeeding.

About all the medicines you take, including prescription (especially ones commonly called TZDs [thiazolidinediones]) and nonprescription medicines, vitamins, and herbal supplements.

How should I use Humalog?

Humalog is a rapid-acting insulin. Take Humalog within fifteen minutes before eating or right after eating a meal.

Always make sure you receive the correct type of Humalog from the pharmacy.

Do not use Humalog if it is cloudy, colored, or has solid particles or clumps in it.

Do not mix Humalog with insulin other than NPH when using a syringe. Do not mix or dilute Humalog when used in a pump.

Inject Humalog under your skin (subcutaneously). Never inject into a vein or muscle. Change (rotate) your injection site with each dose. Make sure you inject the correct insulin and dose.

Depending on the type of diabetes you have, you may need to take Humalog with a longer-acting insulin or with oral antidiabetic medicines.

If you forget to take your dose of Humalog, your blood sugar may go too high (hyperglycemia), which can lead to serious problems like loss of consciousness (passing out), coma, or even death.

Your insulin dose may need to change because of illness, stress, other medicines you take, change in diet, or change in physical activity or exercise.

What are the possible side effects of Humalog?

Low blood sugar is the most common side effect. There are many causes of low blood sugar, including taking too much Humalog. It is important to treat it quickly. You can treat mild to moderate low blood sugar by drinking or eating a quick source of sugar right away. If severe, low blood sugar can cause unconsciousness (passing out), seizures, and death. Symptoms may be different for each person. Be sure to talk to your healthcare provider about low blood sugar symptoms and treatment.

Severe life-threatening allergic reactions (whole-body reactions) can happen. Get medical help right away if you develop a rash over your whole body, have trouble breathing, have a fast heartbeat, or are sweating.

Reactions at the injection site (local allergic reaction) such as redness, swelling, and itching can happen. If you keep having skin reactions or they are serious, talk to your healthcare provider. Do not inject insulin into a skin area that is red, swollen, or itchy.

Skin may thicken or pit at the injection site (lipodystrophy). Do not inject insulin into skin with these types of changes.

Other side effects include low potassium in your blood (hypokalemia) and weight gain.

Serious side effects can include swelling of your hands and feet and heart failure when taking certain pills called thiazolidinediones or “TZDs” with Humalog. This may occur in some people even if they have not had heart problems before. Tell your healthcare provider if you have shortness of breath, swelling of your ankles or feet, or sudden weight gain, which may be symptoms of heart failure. Your healthcare provider may need to adjust or stop your treatment with TZDs or Humalog.

These are not all of the possible side effects. Ask your healthcare providers for more information or for medical advice about side effects.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

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